Bioengineer II, Process Development at Celgene

Seattle, Washington Req #: 1902944
Location: Seattle, Washington, United States
Job Category: Technical Development
Work Location: 400 Dexter Ave N. 98109
Organization: Bioengineering
Employee Status: Full-time
Job Type: Regular
Juno Therapeutics, a Celgene Company, is developing clinical-stage, novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer. We're currently looking for a Bioengineer II to join our Seattle Process Development organization to contribute to both ongoing and new programs within Cell Therapy Development and Operations.
The individual will be a key contributor to the development of Chimeric Antigen Receptor (CARs) and T Cell Receptors (TCRs) early-stage manufacturing process. He/she will design, perform, and interpret complex experiments in collaboration with other process and analytical engineers focused on delivering robust CARs and TCRs manufacturing process. This individual will be involved in the implementation of new technologies and author part of IND submission for FIH programs. The successful candidate will work in a cross-functional and collaborative environment and able to provide guidance for cell culture experiments to enable understanding of process and how it impacts drug product attributes.
Responsibilities will include, but are not limited to, the following:

  • Independently design and execute complex development experiments in order to support cell therapy process development
  • Maintain proficiency in data analysis, statistical analysis, and effective data presentation within a cross-functional team
  • Author technical reports detailing experimental work and summarizing conclusions
  • Manage phase-appropriate process-related document lifecycle as it relates to new process transfer and process improvement implementation
  • Perform process residual modeling for process-related impurity risk assessments
  • Participate in appropriate regulatory filing activities
  • Interact with Analytical Development, Quality, Manufacturing, Regulatory, Pre-Clinical, and Clinical and other personnel as dictated by project need.
  • Leverage and maintain strong relationships with external partners.
  • Define/maintain a safe work environment in accordance with policies/procedures/regulations

Skills/Knowledge Required:
  • B.S. in Biochemical, Chemical, or Biomedical Engineering or Biology related discipline with 5 - 8 years of relevant experience or M.S. with 4-7 years of relevant experience or PhD with relevant experience
  • Familiarity with product lifecycle management
  • Excellent organization skills and ability to handle multiple tasks
  • Highly motivated, willingness to acquire new skills and ability to work without supervision
  • Strong engineering or scientific knowledge appropriate for cellular process development
  • Ability to assess risk and develop contingency plans for process risks
  • Mastery of mammalian cell culture and aseptic technique
  • Experience working in a regulated environment and preparing regulatory documents
  • Interpersonal and leadership skills to work with teams in different functions and organizations

About Us

COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.

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